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DTIC ADA546698: Acute Dermal Irritation Study of JP-8 and S-8 in New Zealand White Rabbits PDF

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AFRL-RH-WP-TR-2011-0054 Acute Dermal Irritation Study of JP-8 and S-8 in New Zealand White Rabbits Jonathan M. Hurley WIL Research Laboratories, LLC 1407 George Road Ashland, OH 44805-8946 LT Dean Wagner Naval Health Research Center Environmental Health Effects Lab 2729 R St. Bldg. 837 Area B Wright Patterson AFB, OH 45433-5707 Teresa R. Sterner Henry M. Jackson Foundation for the Advancement of Military Medicine Wright-Patterson AFB, OH David R. Mattie Biosciences and Performance Division Applied Biotechnology Branch January 2011 Interim Report for June 2008 to September 2008 Air Force Research Laboratory Distribution A: Approved 711th Human Performance Wing for public release; distribution unlimited. Human Effectiveness Directorate Biosciences and Performance Division Applied Biotechnology Branch WPAFB, OH 45433-5707 REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Washington Headquarters Service, Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302, and to the Office of Management and Budget, Paperwork Reduction Project (0704-0188) Washington, DC 20503. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1. REPORT DATE (DD-MM-YYYY) 2. REPORT TYPE 3. DATES COVERED (From - To) 31-01-2011 Interim 4 Jun 2008 – 26 Sep 2008 4 . TITLE AND SUBTITLE 5a. CONTRACT NUMBER Acute Dermal Irritation Study of JP-8 and S-8 in New Zealand White Rabbits 5b. GRANT NUMBER NA 5c. PROGRAM ELEMENT NUMBER 62202F 6. AUTHOR(S) 5d. PROJECT NUMBER Hurley, Jonathon M.**, Wagner, Dean***, Sterner, Teresa R.****, Mattie, OAFW David R.* 5e. TASK NUMBER P0 5f. WORK UNIT NUMBER OAFWP002 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION WIL Research Laboratories, LLC** Naval Health Research Center*** REPORT NUMBER 1407 George Road Environmental Health Effects Lab Ashland, OH 44805-8946 2729 R St. Bldg. 837 Area B Wright Patterson AFB, OH 45433-5707 HJF****, 2729 R Street, Bldg 837 Wright-Patterson AFB, OH 45433-5707 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR'S ACRONYM(S) Air Force Materiel Command* 711 HPW/RHPB Air Force Research Laboratory Human Effectiveness Directorate 11. SPONSORING/MONITORING AGENCY REPORT NUMBER Biosciences and Protection Division Applied Biotechnology Branch AFRL-RH-WP-TR-2011-0054 Wright Patterson AFB OH 45433-5707 12. DISTRIBUTION AVAILABILITY STATEMENT Distribution A: Approved for public release; distribution unlimited. 13. SUPPLEMENTARY NOTES Cleared 18 Jul 2011; 88ABW-2011-3905 14. ABSTRACT The objective of this study was to determine the irritative potential of JP-8, S-8 and a 50/50 volume/volume mixture of JP-8 and S-8 following a single exposure to the skin of albino rabbits. Three groups of three albino rabbits received a single, four-hour, occluded exposure and an additional three groups received a single, four-hour, semi-occluded exposure. Doses (0.5 mL) of the test substances were applied to clipped, unabraded skin. At the completion of all exposures, the bandages were removed and the sites washed. Application sites were evaluated at approximately 30 to 60 minutes; 24, 48 and 72 hours; and 4, 7 and 14 days after patch removal for sites where irritation persisted. Occluded exposures of JP-8 or S-8 resulted in a classification of moderately irritating. Semi-occlusion of either JP-8 or S-8 produced slight irritation. The mixture, however, was slightly irritating in both the occluded and semi-occluded exposures. 15. SUBJECT TERMS JP-8, S-8, jet fuel, synthetic fuel, dermal, skin, mixture 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF 18. NUMBER 19a. NAME OF RESPONSIBLE PERSON ABSTRACT OF PAGES David R. Mattie a. REPORT b. ABSTRACT c. THIS PAGE 69 U U U 19b. TELEPONE NUMBER (Include area code) SAR NA Standard Form 298 (Rev. 8-98) Prescribed by ANSI-Std Z39-18 i THIS PAGE INTENTIONALLY LEFT BLANK. ii TABLE OF CONTENTS List of Figures ................................................................................................................................ iv List of Tables ...................................................................................................................................v Preface........................................................................................................................................... vii 1.0 Summary ...................................................................................................................................1 2.0 Introduction ...............................................................................................................................2 3.0 Materials and Methods ..............................................................................................................3 3.1 Test Substances .............................................................................................................3 3.2 Test Animals .................................................................................................................3 3.3 Test Substance Administration .....................................................................................4 3.4 Observations .................................................................................................................5 3.5 Data Retention ..............................................................................................................6 4.0 Results and Discussion .............................................................................................................6 5.0 Conclusions .............................................................................................................................11 6.0 References ...............................................................................................................................11 Appendix A. Laboratory Test Reports ..........................................................................................12 Appendix B. Animal Room Environmental Conditions ...............................................................17 Appendix C. Study Protocol .........................................................................................................23 List of Abbreviations .....................................................................................................................38 iii LIST OF FIGURES Figure 1. General locations of application sites ..............................................................................5 iv LIST OF TABLES Table 1. Test substances identification ...........................................................................................3 Table 2. Study group assignments ..................................................................................................4 Table 3. Evaluation of dermal reactions .........................................................................................5 Table 4. Descriptive ratings: Mean Primary Dermal Irritation Index .............................................6 Table 5. Individual dermal scores for the JP-8 occluded test group ...............................................7 Table 6. Individual dermal scores for the JP-8 semi-occluded test group ......................................7 Table 7. Individual dermal scores for the S-8 occluded test group ................................................8 Table 8. Individual dermal scores for the S-8 semi-occluded test group ........................................8 Table 9. Individual dermal scores for the JP-8/S-8 occluded test group ........................................9 Table 10. Individual dermal scores for the JP-8/S-8 semi-occluded test group .............................9 Table 11. Individual body weights................................................................................................10 v THIS PAGE INTENTIONALLY LEFT BLANK. vi PREFACE Funding for this project was provided through the Air Force Research Laboratory, Propulsion Directorate, Fuels Branch (Dr Tim Edwards, AFRL/RZPF) and the Alternative Fuels Certification Office (AFMC 77 AESW/LF). This research was conducted under contract FA8601-07-P-0241. The program manager for the contract was LT Dean Wagner, PhD, USN Naval Health Research Center/Environmental Health Effects Laboratory (NHRC/EHEL). The technical manager for the program under which this project was conducted, Fischer Tropsch (F- T) Jet Fuel Toxicity Assessment, was Dr David Mattie. The authors acknowledge the following individuals who also served on a review panel for this program and this project: John Hinz (USAFSAM/OEHTH, Brooks City Base, TX); Gunda Reddy, PhD (USACHPPM, Aberdeen Proving Ground, MD); David Steup, PhD (Shell Oil Company, Houston, TX; Chairman, American Petroleum Institute-Toxicology Task Force); and Errol Zeiger, Ph.D., J.D. (Errol Zeiger Consulting, Chapel Hill, NC). This study, designated WIL-647001, was conducted in compliance with the United States Environmental Protection Agency (U.S. EPA) Good Laboratory Practice Standards (40 CFR Part 792, 1989); the standard operating procedures of WIL Research Laboratories, LLC; and the protocol as approved by the sponsor. Analytical confirmation of the concentration, homogeneity and stability of the dosing mixture was not supplied by the sponsor and was not conducted as part of this study. The study protocol was designed to be in general compliance with the U.S. EPA Office of Prevention, Pesticides and Toxic Substances (OPPTS) Guideline 870.2500 (U.S. EPA, 1998), the Organisation for Economic Cooperation and Development (OECD) Guidelines for Testing of Chemicals, Section 404 (OECD, 2002). This animal study was approved by the Air Force Surgeon General’s Research Human & Animal Research Panel and the WIL Research Animal Care and Use Committee. The study was conducted in a facility accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care, International, in accordance with the Guide for the Care and Use of Laboratory Animals (NRC, 1996). vii THIS PAGE INTENTIONALLY LEFT BLANK. viii

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